# K242349: FoLix

- Pathway: 510(k) (Special)
- Applicant: Lumenis Be, Ltd.
- Decided: Sep 9, 2024 after 32 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K910422 (1992). 325 ancestors in all.
No later device cites it as a predicate yet.
0 of 326 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222790: F65 Laser System, Lumenis Be, Ltd. (2023) Summary page 5.

## Indications for use
The FoLix System, with wavelength of 1565 nm, is indicated for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV who are seeking treatment for hair loss.

Source page: https://510kreport.com/device/K242349
Methodology: https://510kreport.com/methodology